CMV INFECTIONS IN TRANSPLANT RECIPIENTS MedDRA version: 14.1 Level: LLT Classification code 10021819 Term: Infection in marrow transplant recipients System Organ Class: 100000004862 MedDRA version: 14.1 Level: LLT Classification code 10021829 Term: Infection in solid organ transplant recipients System Organ Class: 100000004862
Conditions
Interventions
Product Name: Marabavir
Pharmaceutical Form: Tablet
INN or Proposed INN: marabavir
CAS Number: 176161-24-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Phar
Sponsors
VIROPHARMA INCORPORATED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be =18 years of age. 2. Be a recipient of stem cell or solid organ transplantation. 3. Have documented CMV infection in blood or plasma, with a screening value of =1,000 to =100,000 DNA copies/mL as determined by quantitative PCR or comparable quantitative CMV assay type. Results from either the central laboratory or a local laboratory can be used for qualification. 4. Have CMV infection that does not meet the definition of CMV organ disease at the time of enrollment (see Appendix IV). 5. Have a CMV infection that is not known to be resistant to ganciclovir/valganciclovir, foscarnet, or cidofovir based on genotypic evidence. 6. Have all of the following findings as part of screening laboratory assessment (results from either the central laboratory or a local laboratory can be used for qualification): • Absolute neutrophil count (ANC =500/mm3 [0.5 x 109/L] • Platelet count =25,000/mm3 [25 x 109/L] • Hemoglobin =8 g/dL 7. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy test as part of screening laboratory assessments (pregnancy test results from either the central laboratory or a local laboratory can be used for qualification). Women of child bearing potential also must agree to use an acceptable method of birth control, as determined by the investigator, during the study drug administration period and for 3 months afterward. Hormonal contraceptives should not be used as the sole method of birth control. If male, must agree to use an acceptable method of birth control, as determined by the investigator, during the study drug administration period and for 3 months afterward. 8. Be able to swallow tablets. 9. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed. [NOTE: Subjects must be fully able to give their consent.] Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 144 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: Subjects must not: 1. Be receiving any of the following therapies when study drug is initiated: • ganciclovir • valganciclovir • foscarnet • cidofovir • CMV immune globulin (CMV-IGIV, Cytogam®) • leflunomide • artesunate NOTE: A subject may have received any of the above listed drugs prior to enrollment. If this is the case, these drugs must be discontinued, and a “washout” period of =24 hours is required between the last dose and commencement of dosing with study drug. 2. Have known allergies to one of the study medications (e.g., valganciclovir) or its excipients. 3. Have estimated creatinine clearance (CrCl) <10 mL/min or require dialysis when study drug is initiated. 4. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study drug that would preclude administration of oral/enteral medication. 5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment. 6. Have any serious illness with expected survival less than 6 weeks. 7. Be pregnant (as determined by ß-human chorionic gonadotropin testing prior to initiation of study drug) or breastfeeding. 8. Have received any investigational (unapproved) agent with known anti-CMV activity within 30 days before initiation of study drug. 9. Have any clinically significant medical or surgical condition that in the investigator’s or sponsor’s opinion could interfere with the administration of study drug or interpretation of study results, or compromise the safety or wellbeing of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of different doses of maribavir versus valganciclovir, administered orally for up to 12 weeks, for treatment of CMV infections in recipients of stem cell or solid organ transplants who do not have CMV organ disease. To assess the antiviral activity of different doses of maribavir versus valganciclovir in this subject population.;Secondary Objective: To evaluate the pharmacokinetics and pharmacodynamics of maribavir in this subject population. To identify a maribavir dosing regimen for treatment of CMV infections in future studies.;Primary end point(s): The primary objective of the study is to evaluate the safety and tolerability of different doses of maribavir versus valganciclovir in the study population. The primary analysis of safety will be the evaluation of treatment-emergent adverse events (TEAEs), defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug).;Timepoint(s) of evaluation of this end point: 7 days after the last dose of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy analyses will focus primarily on the antiviral effect of the study drug treatments on plasma CMV DNA concentrations within 3 and 6 weeks; corresponding endpoints will be evaluated using modeling analyses.;Timepoint(s) of evaluation of this end point: 3 weeks | — |
Countries
Austria, Belgium, France, Germany, Spain, United Kingdom
Contacts
Public ContactClinical Study Manager
Viropharma
Outcome results
None listed